OIG Advisory Opinion 26‑11 Offers Guardrails for Free Diagnostic Reports

By Vivian Egbu

In May 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26‑11 (AO 26-11), a favorable opinion concerning a precision oncology company's arrangement to provide consenting patients with a free supplemental multi‑cancer detection (MCD) report in connection with its Medicare-covered blood‑based colorectal cancer (CRC) screening test. OIG expressly concluded that the arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (AKS) if the requisite intent were present and does generate prohibited remuneration under the Beneficiary Inducements Civil Monetary Penalty Law (Beneficiary Inducements CMP). Nevertheless, based on the specific certified facts, OIG concluded that it would not impose administrative sanctions in connection with the arrangement. 

OIG has longstanding concerns with free items or services furnished to providers and patients where those benefits may drive the ordering or provision of federally reimbursable items or services. AO 26-11 is therefore useful to companies evaluating arrangements involving free items or services to providers or patients not because it creates a new exception, but because it illustrates the combination of facts that OIG viewed as presenting sufficiently low fraud-and-abuse risk.

How the Supplemental Cancer Testing Arrangement Worked

The requestor offers an FDA-approved, Medicare-covered blood-based CRC screening test, which Medicare covers once every three years for eligible patients. Using the same blood sample, the requestor applies an investigational algorithm to generate information regarding multiple additional cancers and provides consenting patients a free supplemental report expressing those results. 

To receive the supplemental report, the patient must have a valid order for the CRC screening test from an independent, unaffiliated physician who will use the results in the patient’s management, and the physician must opt in to receive results beyond the CRC. During the data-collection phase, the patient also must consent to receive the supplemental report and participate in an initiative evaluating its clinical utility and supporting FDA approval and future payor coverage of the MCD test.

Why OIG Issued a Favorable Opinion

OIG first concluded that the free supplemental report constituted remuneration because it was a valuable service provided at no cost and could induce patients to select the CRC screening test and, in turn, the requestor's laboratory, over other screening options. Importantly, no AKS safe harbor applied to the arrangement, and the preventive care exception to the Beneficiary Inducements CMP did not apply because neither the CRC screening test nor the MCD test was listed in the applicable U.S. Preventive Services Task Force (USPSTF) Guide to Clinical Preventive Services. OIG nevertheless concluded that the combination of the following factors presented sufficiently low fraud-and-abuse risk:

• Limited risk of overutilization or inappropriate utilization. The supplemental report was available only to patients already eligible for the Medicare-reimbursable CRC screening test who had a valid order from an independent, unaffiliated physician. The MCD analysis was not reimbursable and used the same blood sample, so providing the free supplemental report did not increase federal health care program costs. OIG acknowledged that positive results could lead to follow-up appointments with the ordering provider or referrals to other providers, but viewed those services as clinically driven by the test results rather than inappropriately caused by the arrangement. 
• Limited risk of skewing clinical decision-making. Physicians were not compensated for ordering the CRC screening test or opting in to receive the supplemental report, and access to the report did not depend on the volume or value of referrals. The requestor did not conduct a targeted or incentivized marketing campaign for the supplemental report, did not market it as a remunerative benefit to providers, and used pre-approved, neutral, and objective physician materials that disclosed test performance limitations. 
• Limited risk of inappropriate steering or unfair competition. The requestor's laboratory was already the only laboratory that performed the CRC screening test, meaning that selection of the test necessarily meant selection of the requestor's laboratory even without the free supplemental report. OIG also noted that six of the cancer types detected by the MCD test had no USPSTF-recommended screening test and found that the potential benefit of the supplemental report likely outweighed the limited competitive disadvantage. In addition, the requestor did not engage in direct-to-consumer advertising or promotional activities for the supplemental report.

The Opinion also notes that the arrangement will continue only until the MCD test receives FDA approval or Medicare coverage under a National Coverage Determination.

Takeaways for Diagnostics Companies

The Opinion should be viewed as a fact-specific framework, not as a general authorization for free patient offerings. Like all OIG advisory opinions, the Opinion applies only to the requestor and the specific certified arrangement and cannot be relied upon by other parties. The more useful takeaway is OIG's analytical framework: companies should evaluate whether a free item or service could increase federally reimbursable utilization, skew clinical decision-making, inappropriately steer patients, disadvantage competitors, or increase federal health care program costs. They should then build documented safeguards around those risks.

Diagnostics and other medical products companies considering analogous patient-facing programs should pay particular attention to independent clinical ordering, provider compensation and volume-or-value neutrality, marketing restrictions, objective communications, reimbursement status, clinically driven follow-up, and program scope. Although the MCD test's Breakthrough Device designation was part of the factual background, OIG did not identify the designation itself as an independent basis for the favorable opinion.

“Having worked on the enforcement side, I would not read AO 26-11 as a green light for free patient offerings. Regulators will look past the label and assess whether the structure and safeguards actually limit overutilization, influence on clinical decision-making, and inappropriate steering.” 

Vivian Egbu, Associate Attorney

Bottom Line

AO 26-11 demonstrates that a free patient-facing service can implicate the AKS and Beneficiary Inducements CMP yet still present sufficiently low fraud-and-abuse risk based on the totality of the circumstances. The favorable result turned on a tightly constrained fact pattern and multiple safeguards. Companies should not treat clinical benefit, investigational status, or Breakthrough Device designation as a substitute for a documented fraud-and-abuse analysis.

How Gardner Law Can Help

Gardner Law regularly advises diagnostics, biotech, and medical device companies on AKS and Beneficiary Inducements CMP risk assessments, OIG advisory opinion strategy, and the design of patient support, access, and other patient-facing programs. We help companies evaluate program structure, communications, reimbursement implications, and compliance guardrails before launch. Please contact us to discuss how Advisory Opinion 26-11 may inform a proposed or existing arrangement.